Z-2321-2012Class II

AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585...

Name: Z-2321-2012 AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585...
Creator: AmeriWater Inc
Published: 2012-08-09
License: https://open.fda.gov/license/

AmeriWater LLC. / initiated 2012-08-09 / Terminated / root cause: manufacturing process

FDA source

AmeriWater Inc began a recall of AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585 www.AMERIWATER.com. The AmeriWater MRO Portable Reverse... on 2012-08-09. FDA classified it as Class II and gives the reason as "The firm was notified that a malfunction of the device was caused by an incorrect fuse 32 volt 15 amp fuses instead of 250 volt 15 amp fuses, that was installed in the water system. The incorrect fuse may result in...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2321-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-09
Posted: 2012-09-06
Terminated: 2014-04-17
Recalling firm: AmeriWater LLC.
Product: AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585 www.AMERIWATER.com. The AmeriWater MRO Portable Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmeriWater Portable MROS model is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The AmeriWater Portable MRO1 model is for treatment of up to two patients in a hospital, clinic, or dialysis centers.
Product code: FIP Subsystem, Water Purification
Reason for recall: The firm was notified that a malfunction of the device was caused by an incorrect fuse 32 volt 15 amp fuses instead of 250 volt 15 amp fuses, that was installed in the water system. The incorrect fuse may result in excessive heat in the fuse holder eventually resulting in failure of the device to operate.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, AmeriWater, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated August 9, 2012, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and quarantine the product subject to recall; remove affected devices from service until the correction is completed to prevent malfunction of the device during patient treatment; and complete and return the attached response form to AmeriWater within 30 days via fax to 937/461-1988 Attn: Quality Assurance. AmeriWater dealer will be contacting their customers to schedule replacement of the fuses. If you have any questions, contact your local AmeriWater dealer or AmeriWater customer service at 1-800-535-5585.
Quantity in commerce: 80 Units
Distribution: Worldwide distribution: USA (nationwide) including states of: AL, AR, CO, CT, FL, GA, IL, IN, KS, MA, MD, MO, MS, NC, NY, OH, OK, SC, TN, TX and VA; and country of: Canada.
Product codes and lots: Model Number MROS, Catalog #00MROS20, 00MROS21 & Model Number MRO1, Catalog #00MRO120, and 00MRO121; Model Number(s): MROS and MRO1; Serial #'s 31000 to 31079.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2321-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2321-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-12	2012-09-06

Product code FIP

K111740Class IIAmeriwater Mro Portable Reverse Osmosis System - Single Patient, 1 to 3 StationAmeriwater / cleared 2011-10-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)